As part of the agreement, Sharp will offer sterile fill/finish to augment its existing clinical manufacturing service to the pharmaceutical, biotech and clinical research sectors.

Massachusetts-based BSM is a fill/finish contract manufacturer incorporating 100% isolator-based sterile filling to its lines for syringes, vials and cartridges for the biotech and pharmaceutical industries. The isolator-based filling technology removes the risk of human contamination from the formulation and filling process.

Shawn Kinney, CEO of BSM said: “We are excited to be working with Sharp, a high-quality contract services organisation that can offer our clients downstream packaging, labelling, storage and distribution services in a fully seamless manner.”

Through the partnership, BSM will be able to offer its clients a comprehensive portfolio of complementary clinical trial supply and management services including analytical testing, stability, clinical and commercial packaging, serialisation, IRT services, QP services, storage and distribution.

Frank Lis, President at Sharp Clinical, said: “This partnership with BSM is a natural extension to the clinical services we offer our clients and one that will see both parties benefit greatly from each other’s experience and expertise.

“BSM will be able to offer broader clinical trial services to its clients and a more harmonised customer experience, while Sharp will deepen its clinical manufacturing capabilities.”

Sharp currently has dedicated clinical services facilities in Bethlehem Pennsylvania and in Wales, UK both offering a broad spectrum of clinical services including cold storage, analytical, formulation development and commercial packaging.

Mr Lis continued: “Our clients will benefit enormously from the depth of expertise available to them through the team at BSM. We are very excited to be collaborating closely with such an industry leader in manufacturing and fill/finish and for the future of this relationship.

The Sharp BSM partnership agreement comes into effect immediately.

ABOUT SHARP

Sharp, part of UDG healthcare, is a global leader in contract packaging and clinical services. Operating from eight state-of-the-art facilities across the US and Europe, Sharp has built an international reputation for delivering cost-effective blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, formulation and manufacturing services, label design and printing. Sharp is also a world leader in ’Track and Trace’ and serialisation services, with over nine years’ experience in implementing serialized solutions for its pharma clients.

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment?
Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
More info >>

The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level. More info >>